RegulationFast Track (United States), Orphan Drug (United States), Orphan Drug (European Union), Conditional marketing approval (China), Breakthrough Therapy (China), Priority Review (China)

Structure/Sequence

Molecular FormulaC31H35F3N6O7S2

InChIKeyLEVIGHXVOVROGW-UHFFFAOYSA-N

CAS Registry1421783-64-3

Clinical Trials associated with Olverembatinib

NCT07178912

/ Not yet recruitingPhase 2IIT

Phase II Study of the Combination of Subcutaneous Blinatumomab and Olverembatinib in Patients With Philadelphia Chromosome (ph)-Positive and/or BCR::ABL1 Positive Acute Lymphoblastic Leukemia (ALL)

To find out if giving blinatumomab as injections under the skin and olverembatinib can help to control the disease in patients with Ph-positive ALL.

Start Date27 Aug 2026

Sponsor / Collaborator

The University of Texas MD Anderson Cancer Center

[+2]

NCT07454226

/ RecruitingNot ApplicableIIT

An Open-Label, Single-Arm, Phase II Exploratory Study of ABL and JAK Kinase Inhibitors With Chemotherapy and Venetoclax in Adult Patients With Ph-like ALL

This open-label, non-randomized, phase II exploratory study aims to evaluate the efficacy and safety of combining pathway-specific tyrosine kinase inhibitors with chemotherapy and venetoclax in patients with newly diagnosed Ph-like acute lymphoblastic leukemia (ALL). Patients are stratified by genetic alteration: those with ABL class fusions (ABL1, ABL2, PDGFRA, PDGFRB) receive olverembatinib, while those with JAK pathway alterations (CRLF2 rearrangement, JAK mutation/fusion, EPOR fusion, SH2B3 deletion, IL7R mutation) receive Gecacitinib. Both groups undergo sequential induction, consolidation, intensification, and maintenance therapy as per protocol.
The primary endpoint is the rate of flow cytometry minimal residual disease (MRD)-negative complete remission (CR MRD-) at 3 months after induction therapy. Secondary endpoints include overall complete remission rate, NGS MRD-negative CR rate at 3 months, overall survival (OS), disease-free survival (DFS), relapse-free survival (RFS), cumulative incidence of relapse, and 60-day mortality.

Start Date30 May 2026

Sponsor / Collaborator

Hematology Hospital of Chinese Academy of Medical Sciences

ChiCTR2600124345

/ Not yet recruitingEarly Phase 1IIT

Exploratory study of PULSAR radiotherapy concurrent with apalutamide and toripalimab combined with TAS-102 for the treatment of liver metastases from pMMR/MSS colorectal cancer in the third-line or higher settings

Start Date11 May 2026

Sponsor / Collaborator

The Second Affiliated Hospital of Nanchang University

100 Clinical Results associated with Olverembatinib

100 Translational Medicine associated with Olverembatinib

100 Patents (Medical) associated with Olverembatinib

102

Literatures (Medical) associated with Olverembatinib

01 Jun 2026·TRANSPLANT IMMUNOLOGY

T315I-mutated chronic myeloid leukemia with blast crisis relapse 10 years after allo-HSCT: A case report of second transplantation combined with olverembatinib maintenance therapy

Article

Author: Ji, JiaJuan ; Fan, ShengJin ; Zhu, YuTing ; Zhao, YanQiu ; Ding, PeiWen ; Luo, Dan ; Guo, Dan ; Liu, Jie

Chronic myeloid leukemia (CML) is a myeloproliferative neoplasm characterized by the presence of the Philadelphia chromosome and the resulting fusion proteins with abnormal tyrosine kinase activity. The treatment of CML includes allogeneic hematopoietic stem cell transplantation (allo-HSCT) and TKI drug therapy. The BCR::ABL1 T315I mutation in CML leads to resistance to first- and second-generation tyrosine kinase inhibitors (TKIs), but is sensitive to two third-generation TKIs, olverembatinib and ponatinib. Olverembatinib, an oral third-generation BCR::ABL1 TKI, has preclinical activity against T315I-mutated CML. Here, we present a case of a CML patient with the T315I mutation who experienced late relapse with blast crisis 10 years after allo-HSCT. Following hematologic recovery and achievement of major molecular response (MMR) through induction therapy, the patient underwent a second allo-HSCT from his haploidentical sister. After successful engraftment, the patient received regular consolidation maintenance therapy with olverembatinib.

01 Jun 2026·JOURNAL OF BIOLOGICAL CHEMISTRY

Pharmacological targeting of the mycothiol cysteine ligase MshC in Mycobacterium abscessus

Article

Author: Liu, Yi ; Nguyen, Thanh Quang ; Giannini, Greta Carola ; Larrouy-Maumus, Gerald ; Kremer, Laurent ; Hamela, Claire ; Boeck, Lucas ; Pang, Luping

The prevalence of pulmonary diseases caused by Mycobacterium abscessus is on the rise and surpasses tuberculosis in many countries. However, intrinsic resistance of this pathogen to antibiotics profoundly limits our therapeutic arsenal, and new chemotherapeutic agents and targets are urgently needed. Mycothiol (MSH), the major thiol in mycobacteria, plays an important role in resistance to oxidative stress. Previous work in Mycobacterium smegmatis and Mycobacterium tuberculosis indicates that the ATP-dependent cysteine ligase MshC catalyzes the penultimate step in MSH biogenesis. Here, we investigated whether MshC represents a potent drug target in M. abscessus. CRISPRi was used to demonstrate that mshC is essential in vitro and during infection in zebrafish larvae. Subsequently, in silico drug screening identified three potential MshC-binding molecules, namely rebastinib, olverembatinib and SB-224289, significantly inhibiting M. abscessus growth and MSH production. Spontaneous missense mutations in MshC generated cross-resistance to all three compounds. Mapping the mutations conferring resistance on a MshC three-dimensional homology model defined the enzyme catalytic site as the potential drug binding cavity. Additionally, overexpression of mshC in a susceptible M. abscessus strain increased resistance levels to rebastinib, olverembatinib and SB-224289, but not to rifabutin. Conversely, reduced mshC expression levels in the CRISPRi mutant increased susceptibility to the inhibitors. Systematic assessment of olverembatinib and SB-224289 in combination with 18 additional drugs revealed distinct synergistic and antagonistic interactions. These results emphasize a yet unexploited chemical structure class against M. abscessus and highlight the potential of targeting the MSH pathway for future translational developments against M. abscessus lung diseases.

12 May 2026·Leukemia & Lymphoma

Olverembatinib and high-dose methotrexate in acute lymphoblastic leukemia: delayed methotrexate clearance and increased nephrotoxicity

Article

Author: Zhang, Ping ; Wang, Xiao-dan ; Liao, Ying-xi ; Wang, Xiao-xu ; Li, Shan ; Tian, Ji-xin ; Miao, Wen-juan ; Sun, Xin-yuan ; Liu, Dong-xue

The novel tyrosine kinase inhibitors (TKIs), characterized by superior potency and selectivity against BCR-ABL1 kinase, are increasingly administered concomitantly with high-dose methotrexate (HD-MTX) for BCR-ABL1-positive acute lymphoblastic leukemia. However, data on TKI-MTX drug interactions remain scarce. We retrospectively analyzed 49 adults who received HD-MTX, of whom 10 were co-treated with olverembatinib and 17 with flumatinib. MTX clearance was estimated using a population pharmacokinetic model. Olverembatinib significantly reduces MTX clearance (35.1% slower than no-TKI) and elevates 48-hour serum concentration above the safety threshold in 80% of cases, resulting in a 60% incidence of ≥ grade 2 nephrotoxicity and a 70% rate of acute kidney injury (AKI)-both markedly higher than with HD-MTX alone (4.6% and 27.3%, respectively). Flumatinib likewise lowered MTX clearance and raised ≥ grade 2 nephrotoxicity to 29.4%, yet neither effect reached statistical significance. Temporary withdrawal of olverembatinib before HD-MTX infusion may prevent MTX-related nephrotoxicity.

247

News (Medical) associated with Olverembatinib

15 Jun 2026

·www.biospace.com

Ascentage Pharma Presents Multiple Clinical Updates at EHA2026 Congress

Poster presentations from ongoing clinical trials of two core assets, olverembatinib and lisaftoclax, highlight global innovation capabilities in hematologic malignancies ROCKVILLE, Md. and SUZHOU, China, June 14, 2026 (GLOBE NEWSWIRE) -- Ascentage Pharma Group International (NASDAQ: AAPG; HKEX: 6855), a global, commercial-stage, integrated biopharmaceutical company engaged in the discovery, development and commercialization of novel therapies to address unmet medical needs in cancer, announced today that seventeen clinical updates from its core assets were presented at the 31 st Congress of the European Hematology Association (EHA2026), including eight poster presentations. The presentations featured data from ongoing clinical studies of olverembatinib (HQP1351), the first third-generation BCR-ABL1 inhibitor approved in China, and lisaftoclax (APG-2575), the first approved China-developed Bcl-2 selective inhibitor. The EHA2026 Congress convened in Stockholm, Sweden, from June 11 to 14, 2026. At the EHA2026 Congress, presentations on olverembatinib comprised key concurrent updates across two therapeutic areas: chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). In CML, olverembatinib demonstrated deep and durable responses in patients with chronic-phase CML (CML-CP) without the T315I mutation, in whom the disease was resistant and/or intolerant to first-line TKI therapy, supporting its potential as a second-line treatment option. For CML-CP patients who have failed treatment with at least two prior TKIs, olverembatinib can be used as a standard treatment option. In addition, olverembatinib showed positive clinical data in CML patients with multiline TKI resistance and co-occurring high-risk genetic mutations. In Ph+ ALL, olverembatinib continued to demonstrate robust clinical response, with updated data from the first-line global registrational Phase III study (POLARIS-1) further validating its deep response rate and manageable safety profile. The chemotherapy-free combination regimen with lisaftoclax yielded encouraging clinical data in subpopulations such as pediatric patients with relapsed/refractory Ph+ ALL. Updated data from the registrational Phase II study of lisaftoclax in chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) were also presented. Stratified analyses correlating baseline characteristics with prognosis provided important insights that will inform refinement of treatment strategies and optimization of individualized dosing regimens across different patient populations. The real-world data on lisaftoclax in myeloid neoplasms also provides robust evidence for its clinical utility. Yifan Zhai, MD, Chief Medical Officer of Ascentage Pharma, said: “The clinical updates on olverembatinib and lisaftoclax presented at EHA2026 further validate the therapeutic value of these two key assets in the global hematologic malignancy field. Olverembatinib has the potential to become an important treatment option for CML, while offering new treatment possibilities for Ph+ ALL patients. The updated data from the registrational Phase II study of lisaftoclax in CLL/SLL will help guide individualized dosing strategies across different patient populations. Its real-world data in myeloid malignancies further strengthens our confidence in its clinical application among such patients. We are particularly encouraged by the promising combination data. Looking ahead, we will continue to accelerate the global clinical development of our key assets, while actively exploring more innovative combination treatment strategies to provide meaningful treatment options for patients around the world.” Key highlights of the selected poster presentations at EHA2026 are as follows (for more information of the Company’s candidates, please visit the official EHA website): EFFICACY OF OLVEREMBATINIB IN PATIENTS WITH CHRONIC-PHASE CHRONIC MYELOID LEUKEMIA (CP-CML) WITH PRIOR RESISTANCE TO PONATINIB OR ASCIMINIB AND ASXL1 MUTATIONS Abstract Number: EHA-3991 (PS1727) First Author: Elias Jabbour, MD, Department of Leukemia, The University of Texas MD Anderson Cancer Center Key Highlights: This Phase Ib study performed mutational analyses on 22 patients with ponatinib- and/or asciminib-resistant CP-CML and evaluated the antileukemic activity of olverembatinib across different mutational backgrounds. ASXL1 mutations were present in 40.9% (9/22) of patients. After olverembatinib treatment, 44.4% (4/9) of patients with ASXL1 mutations achieved clinical responses, including 22.2% (2/9) who achieved MMR, one of whom achieved MR4.5. This study provided the first evidence that olverembatinib is active in patients with ponatinib- and/or asciminib-resistant CP-CML, including those harboring challenging genotypes such as ASXL1 mutations, highlighting its potential as a treatment option for patients with multi-line TKI-resistant disease. UPDATED EFFICACY AND SAFETY OF OLVEREMBATINIB (HQP1351) AS SECOND-LINE THERAPY IN PATIENTS WITH CHRONIC-PHASE CHRONIC MYELOID LEUKEMIA (CP-CML) Abstract Number: EHA-3388 (PS1733) First Author: Weiming Li, MD, Department of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Key Highlights: This single-arm, multicenter, open-label Phase II study evaluated olverembatinib as a second-line treatment in patients with CP-CML without the T315I mutation. Among 42 evaluable patients, the complete cytogenetic response (CCyR) rate was 76.2% and the major molecular response (MMR) rate was 47.6%. Responses deepened over time with longer treatment duration, and olverembatinib exhibited manageable tolerability with no treatment-related deaths. These findings support the potential of olverembatinib to induce durable and deep responses in patients with CP-CML without the T315I mutation whose disease was resistant and/or intolerant to first-line TKI therapy, further supporting its role as a second-line treatment option. THE EFFICACY AND SAFETY OF SWITCHING TO OLVEREMBATINIB OR CONTINUING ORIGINAL TKI THERAPY IN CML-CP PATIENTS TREATED WITH AT LEAST TWO PRIOR TKIS: A PROSPECTIVE, MULTICENTER, CONTROLLED TRIAL Abstract Number: EHA-4595 (PS1728) First Author: Bingbing Wen, the Second People’s Hospital of Shenzhen Key Highlights: This prospective, multicenter, controlled trial enrolled 105 patients with CML-CP who had received at least two prior TKIs for ≥18 months and failed to achieve MMR. Patients were assigned in a 1:2 ratio to either switch to olverembatinib (40 mg orally every other day) or continue their most recent TKI therapy. Results showed that the 6-month MMR rate was significantly higher in the olverembatinib group than in the control group (54.3% vs 10.0%; P<0.001). At 12 months, the cumulative incidence of MMR was 57.14% in the olverembatinib group compared with 21.43% in the control group (P<0.0001). Common grade 3/4 hematologic treatment-emergent adverse events (TEAEs) included thrombocytopenia (42.86%) and anemia (17.14%). Grade 3/4 non-hematologic adverse events were rare. Notably, 78.57% of adverse events related to prior TKI therapy improved after patients switched to olverembatinib. These findings support olverembatinib as a potential standard of care for patients with CML-CP previously treated with at least two TKIs. UPDATED RESULTS OF POLARIS-1 (PART 1), A GLOBAL REGISTRATIONAL PHASE 3 STUDY: OLVEREMBATINIB COMBINED WITH LOW-INTENSITY CHEMOTHERAPY IN NEWLY DIAGNOSED PH+ ALL Abstract Number: EHA-3437 (PS1479) First Author: Suning Chen, The First Affiliated Hospital of Soochow University Key Highlights: This global, multicenter, registrational Phase III study (POLARIS-1 Part 1) is evaluating the efficacy and safety of olverembatinib in combination with reduced-intensity chemotherapy in patients with newly diagnosed Ph+ ALL. A total of 55 patients were enrolled. By the end of induction, the CR/CRi rate reached 94.4% and the MRD-negative CR rate reached 63.0%. MRD-negativity rates increased over time, reaching 93.1% by the end of cycle 9. The regimen demonstrated a manageable safety profile, with no meaningful differences in efficacy or safety observed between the 30 and 40mg dose groups. Encouraging activity was also observed in patients with adverse prognostic genotypes, including IKZF1 plus . These findings suggest that olverembatinib combined with low-intensity chemotherapy may induce rapid, deep, and sustained MRD-negative responses in patients with newly diagnosed Ph+ ALL, while maintaining a favorable safety profile, and provide important evidence supporting its use in the frontline setting. SAFETY AND PRELIMINARY EFFICACY OF OLVEREMBATINIB (HQP1351) COMBINED WITH LISAFTOCLAX (APG-2575) IN PEDIATRIC PATIENTS WITH RELAPSED/REFRACTORY (R/R PH+ ALL): RESULTS OF A PHASE 1B STUDY Abstract Number: EHA-4691 (PS1473) First Author: Jingliao Zhang, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College Key Highlights: This open-label, dose-escalation Phase Ib study evaluated olverembatinib in combination with lisaftoclax in pediatric patients with relapsed/refractory (R/R) Ph+ ALL who are resistant or intolerant to at least one prior TKI. A total of 17 patients were enrolled, with a median age of 13 years, and 40% harbored ABL1 mutations, including T315I . Among nine efficacy-evaluable patients, the combination achieved an overall response rate (ORR) of 88.9%, an MRD-negativity rate of 66.7% (8/12 at cycle 2 day 28), and 93.3% of patients (14/15 at cycle 2 day 28) achieved MMR or better. Both agents were detectable in cerebrospinal fluid (CSF), providing evidence of CNS penetration, and demonstrated activity across ABL1 mutation subgroups. The regimen showed a manageable safety pro no treatment-related deaths. These findings support the potential of this chemotherapy-free oral dual-targeted regimen to induce rapid and deep remissions, and may provide a novel treatment option for pediatric patients with R/R Ph+ ALL. REAL-WORLD EFFICACY AND SAFETY OF LISAFTOCLAX IN MYELOID NEOPLASMS: A MULTICENTER STUDY Abstract Number: EHA-5454 (PF562) First Author: Chen Cao, Qilu Hospital of Shandong University Key Highlights: This multicenter real-world (retrospective) study evaluated the efficacy and safety of the novel BCL-2 inhibitor lisaftoclax in patients with myeloid neoplasms. A total of 30 patients (median age 63) were enrolled, including 25 patients with acute myeloid leukemia (AML, 83%), 3 with myelodysplastic syndromes (MDS, 10%), and 2 with chronic myelomonocytic leukemia (CMML, 7%). In patients with AML, the CR/CRi rate reached 72%, with the highest response observed in the ELN low-risk subgroup (87%). Among patients achieving CR/CRi, the MRD-negativity rate was 61%. The CR/CRi rate was 100% in patients with NPM1 mutations and 83% in patients with IDH2 mutations. Among the three patients with MDS, two achieved CRi. Regarding safety, grade≥3 treatment-emergent adverse events (TEAEs) were primarily hematologic adverse events, including thrombocytopenia (27%), anemia (23%), and neutropenia (20%). Overall safety was manageable. These findings demonstrate promising efficacy and manageable safety of lisaftoclax in the real-world treatment of myeloid neoplasms, particularly AML. CORRELATION OF BASELINE CHARACTERISTICS WITH PROGNOSIS IN PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA/SMALL LYMPHOCYTIC LYMPHOMA (CLL/SLL) TREATED WITH LISAFTOCLAX (APG-2575) IN A PIVOTAL PHASE 2 STUDY Abstract Number: EHA-3984 (PS1713) First Author: Keshu Zhou, Henan Cancer Hospital Key Highlights: This correlative analysis from the pivotal Phase II study (NCT05147467) evaluated associations between baseline characteristics and prognosis in patients with R/R CLL/SLL treated with lisaftoclax. The study enrolled 77 patients with R/R CLL/SLL refractory to BTKis who received lisaftoclax 600 mg once daily. Among 72 evaluable patients, the median progression-free survival (PFS) was 23.9 months and the Independent Review Committee (IRC)-assessed ORR was 62.5%. Further analyses showed that TP53 mutation/del(17p), complex karyotype (CK), and mutations in SF3B1, KIT, BLM, and SETD2 were associated with significantly shorter PFS. Complex karyotype and tumor size were identified as independent risk factors for shorter PFS. These findings demonstrate that lisaftoclax has clinical activity in patients with R/R CLL/SLL refractory to BTKi therapy. Additionally, these data may help to identify patients with poorer prognosis based on baseline risk characteristics, supporting future risk stratification and risk-adapted combination treatment strategies. *Olverembatinib and lisaftoclax are currently under investigation and have not yet been approved by the US FDA. About Ascentage Pharma Ascentage Pharma Group International (NASDAQ: AAPG; HKEX: 6855) (“Ascentage Pharma” or the “Company”) is a global, commercial stage, integrated biopharmaceutical company engaged in the discovery, development and commercialization of novel, differentiated therapies to address unmet medical needs in cancer. The Company has built a rich pipeline of innovative drug products and candidates that include inhibitors targeting key proteins in the apoptotic pathway, such as Bcl-2 and MDM2-p53, next-generation kinase inhibitors, and protein degraders. The Company’s first approved product, olverembatinib, is the first novel third-generation BCR-ABL1 inhibitor approved in China for the treatment of patients with CML in chronic phase (CML-CP) with T315I mutations, CML in accelerated phase (CML-AP) with T315I mutations, and CML-CP that is resistant or intolerant to first and second-generation TKIs. It is covered by the China National Reimbursement Drug List (NRDL). Ascentage Pharma is currently conducting an FDA- and EMA-cleared registrational Phase III trial, called POLARIS-2, of olverembatinib for CML, as well as an FDA- and EMA-cleared registrational Phase III trials for patients with newly diagnosed Ph+ ALL, called POLARIS-1, and SDH-deficient GIST patients, called POLARIS-3. The Company’s second approved product, lisaftoclax, is a novel Bcl-2 inhibitor for the treatment of various hematologic malignancies. Lisaftoclax has been approved by China’s National Medical Products Administration (NMPA) for the treatment of adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have previously received at least one systemic therapy including Bruton’s tyrosine kinase (BTK) inhibitors. The Company is currently conducting four global registrational Phase III trials: the FDA- and EMA- cleared GLORA study of lisaftoclax in combination with BTK inhibitors in patients with CLL/SLL previously treated with BTK inhibitors for more than 12 months with suboptimal response; the GLORA-2 study in patients with newly diagnosed CLL/SLL; the GLORA-3 study in newly diagnosed, elderly and unfit patients with AML; and the FDA- and EMA-cleared GLORA-4 study in patients with newly diagnosed higher risk MDS. Leveraging its robust R&D capabilities, Ascentage Pharma has built a portfolio of global intellectual property rights and entered into global partnerships and other relationships with numerous leading biotechnology and pharmaceutical companies, such as Takeda, AstraZeneca, Merck, Pfizer, and Innovent, in addition to research and development relationships with leading research institutions, such as Dana-Farber Cancer Institute, Mayo Clinic, National Cancer Institute and the University of Michigan. For more information, visit Cautionary Note Regarding Forward-Looking Statements This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements, other than statements of historical facts, contained in this press release may be forward-looking statements, including statements that express Ascentage Pharma’s opinions, expectations, beliefs, plans, objectives, assumptions or projections regarding future events or future results of operations or financial condition. These forward-looking statements are subject to a number of risks and uncertainties as discussed in Ascentage Pharma’s filings with the SEC, including those set forth in the sections titled “Risk factors” and “Cautionary note regarding forward-looking statements” in its Annual Report on Form 20-F for the year ended December 31, 2025, filed with the SEC on April 29, 2026, the sections headed “Forward-looking Statements” and “Risks Factors” in the prospectus of the Company for its Hong Kong initial public offering dated October 16, 2019, and other filings with the SEC and/or The Stock Exchange of Hong Kong Limited where the Company’s ordinary shares are listed it has made or it makes from time to time that may cause actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. The forward-looking statements contained in this presentation do not constitute profit forecast by the Company’s management. As a result of these factors, you should not rely on these forward-looking statements as predictions of future events. The forward-looking statements contained in this press release are based on Ascentage Pharma’s current expectations and beliefs concerning future developments and their potential effects and speak only as of the date of such statements. Ascentage Pharma does not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Contact Information Investor Relations: Stella Yang Ascentage Pharma Stella.Yang@ascentage.com +1 (301) 792-6286 Ascentage Pharma IR@ascentage.com +1 (301) 792-6286 Stephanie Carrington ICR Healthcare AscentageIR@icrhealthcare.com +1 (646) 277-1282 Media Relations: Sean Leous ICR Healthcare AscentagePR@icrhealthcare.com +1 (646) 866-4012

Clinical ResultPhase 2Phase 3Phase 1Drug Approval

03 Jun 2026

·www.fiercepharma.com

As Akeso takes center stage at ASCO, China biotech industry cements its coming of age

Above the scientific discussions and deal talks at ASCO 2026, the dark cloud of geopolitics hovered over the Chicago convention center. In 2017, a little-known company called Nanjing Legend Biotech walked into the ASCO annual meeting at the 11th hour, dropped a 100% objective response rate for a cell therapy that would become Carvykti, and single-handedly put Chinese biotech on the global map. Nearly a decade later, taking the center stage at ASCO 2026, Akeso’s ivonescimab made history by offering the first-ever Chinese data set to command a coveted spot on the plenary session.“We see a lot of sophistication and skill in Chinese companies,” Marjorie Green, M.D., head of oncology global clinical development at Merck Research Laboratories, said in an interview.The maturity of the Chinese biopharma industry is evidenced by the deals it has signed. Through a potential $3.3 billion pact in 2024, Merck secured global rights to a PD-1xVEGF competitor to ivonescimab from China’s LaNova Medicines. The following year, LaNova was acquired by Sino Biopharm in the first full acquisition of an innovative Chinese biotech by a domestic large pharma on record, a milestone widely viewed as evidence of an increasingly mature ecosystem. At ASCO, ivonescimab’s landmark overall survival (OS) win against a PD-1 inhibitor in their respective combinations with chemotherapy in first-line squamous non-small cell lung cancer (NSCLC) was just one of numerous studies of Chinese assets that reshaped the conference’s narrative.In what Natalie Vokes, M.D., of the MD Anderson Cancer Center said “could well be a practice-changing study” if validated in a global trial, Kelun-Biotech’s TROP2 antibody-drug conjugate, sac-TMT, paired with Keytruda, slashed the risk of progression or death by 65% versus Keytruda alone in Chinese patients with previously untreated PD-L1-positive NSCLC. That drug, too, also has been swept into the Merck universe.Even though the study used Keytruda monotherapy as the comparator, Vokes noted on stage that the progression-free survival (PFS) efficacy of the sac-TMT combo compares favorably to historical data for Keytruda plus chemo."I go to bed and wake up with in my mind there are two things, China and AI," Pfizer CEO Albert Bourla said.Opening that same lung cancer session on May 29, Dizal Pharma showed that its small molecule tyrosine kinase inhibitor Zegfrovy improved PFS by 45% compared with chemo among first-line NSCLC patients with EGFR exon 20 insertion mutations, the exact field where Takeda had stumbled with Exkivity. Compared to Johnson & Johnson’s antibody Rybrevant, used alongside chemo, Zegfrovy offers “the advantage of a single oral agent administration,” John Heymach, M.D., chair of thoracic/head and neck medical oncology at MD Anderson, noted during his presentation.The third Chinese asset sharing the same stage, a next-generation RET inhibitor called lunbotinib, also hails from Kelun.“Over the last three years, especially in emerging fields like bispecifics and ADCs, China has become so essential, some are even saying that if a session doesn’t include presentations or data from China, it’s simply not worth attending,” Dajun Yang, M.D., Ph.D., CEO of Ascentage Pharma, said in an interview with Fierce. “In sectors like bispecifics, bispecific ADCs or protein degraders, up to a third of the studies presented are coming out of China.” The speed engineNew compounds are entering clinical trials in China at an unprecedented speed. In 2015, Ascentage secured five Investigational New Drug (IND) clearances from Chinese regulators across two molecules. At the time, that total IND number ranked third among Chinese biopharmas. Today, China sometimes clears 20 IND approvals in a single week, Yang noted.The sheer volume has caught attention across the Pacific. During a speech to FDA staffers on April 1, then-FDA head Marty Makary, M.D., flagged that China today has four times more phase 1 initiations than the U.S.Paradoxically, China’s IND review timeline is not as fast as the U.S. FDA, Yang observed. Instead, the pace of preclinical lab tests helps set China apart in the speed of the entire IND process. For its BTK degrader candidate APG-3288, Ascentage entered good laboratory practice (GLP) toxicology studies in April 2025 and received FDA IND clearance two days before Christmas—an eight-month process from an IND bid to a regulatory green light.If the GLP work had been done in the U.S., simply waiting in line to launch primate studies could have taken half a year on its own, Yang noted. At ASCO, Ascentage shared phase 1b updates of its olverembatinib, a China-approved third-generation BCR-ABL1 inhibitor and potential competitor to Novartis’ blockbuster Scemblix, in patients with lymphoid blast phase chronic myeloid leukemia (CML) or Ph+ B-cell precursor acute lymphoblastic leukemia, as well as in second-line chronic-phase CML.The drug is commercially partnered with Innovent Biologics in China, while Takeda holds an option to in-license the TKI through a potential $1.3 billion deal signed in 2024. Takeda’s ties with China have been deepening. More recently, the Japanese pharma paid none other than Innovent $1.2 billion upfront for rights to two oncology candidates. One of the programs, a potential first-in-class PD-1/IL-2 bispecific fusion protein called IBI363 (TAK-928), showcased phase 1 proof-of-concept lung cancer data at ASCO 2026. “We actually found that China biotechs currently are just a tremendous source, honestly, of innovation,” Takeda’s oncology R&D head, P.K. Morrow, M.D., told Fierce. “In the past, one might have looked at it as follow-on molecules, and that is completely untrue now.” ‘Their second step’With Takeda, Innovent will co-develop and co-commercialize IBI363. Until recently, this deal structure was not very common compared with early research collaborations, pure licensing arrangements or asset purchases between Chinese biotechs and large multinational pharmas. Similar collaboration terms can also be found in Bristol Myers Squibb’s $15.2 billion, broad partnership with Hengrui Pharma.On the eve of ASCO 2026, Innovent stole the limelight with its own massive multi-asset partnership with Pfizer, which also includes co-development and co-commercialization terms around four assets.“These are clear votes of confidence on the abilities of at least these specific companies—Hengrui and Innovent—to conduct development and generate assets at a similar level to that of their partner multinational pharmas,” Helen Chen, global sector co-head for healthcare and a Greater China managing partner of L.E.K. Consulting, told Fierce.Pfizer examined Innovent’s drug development track record and their discovery engine and was “very excited in what we saw about the quality,” Johanna Bendell, M.D., Pfizer’s chief development officer of oncology, said in an interview.Bendell’s boss is perhaps blunter. “I go to bed and wake up with in my mind there are two things: China and AI,” Pfizer CEO Albert Bourla said in a podcast aired May 20, before quickly adding, “and politics, unfortunately.”Despite the vote of confidence, Innovent CEO Michael Yu, Ph.D., acknowledges that Innovent’s internal capabilities are not yet strong enough to support a solo act on the global market. “That’s why we have to find a company that is willing to take this journey together with us,” Yu told Fierce.The four assets to be co-developed under the Pfizer pact also drew interest from other companies, enabling Innovent to press for the co-development terms, Yu said. For IBI363, Innovent even left higher bids on the table to choose Takeda because the partner, besides global oncology know-how, is willing to work under a co-development framework, he said.For his part, Bourla has already sensed that in deal talks with Chinese companies, Western players no longer hold an overwhelmingly dominant position. “They are focusing on early right now, because they can’t have global clinical development teams yet, and they don’t have commercial development teams yet,” he said during the podcast with Norges Bank Investment Management CEO Nicolai Tangen. “So I’m sure that on the early stage, they would be very quickly better and more productive than us within two years. Then it comes to, they need to transition to being able to take those molecules and bring them to the world alone rather than together with us. And I think that will be their second step.” A China data question? BMS had been a believer in Chinese innovation even before teaming up with Hengrui. At ASCO, the New Jersey pharma’s chief medical officer, Cristian Massacesi, M.D., touted the broad potential of a first-in-class EGFRxHER3 bispecific antibody-drug conjugate (ADC), which the pharma giant bought from China’s Sichuan Biokin Pharmaceutical for $800 million upfront. In two phase 3 trials run by Biokin in China, the novel ADC bested chemo on both PFS and OS in patients with previously treated triple-negative breast cancer and esophageal cancer, separately. BMS has now started to conduct registrational studies of the asset globally.But amid the rounds of applause at ASCO and the stream of multibillion-dollar transactions, doubts and uncertainties linger. Despite a positive OS readout from Harmoni-6 that exceeded expectations, Akeso’s stock price first shot up, then dropped Monday as its findings’ translatability from China to a global population came into question.“It’s not necessarily a China question versus a non-China question,” Merck’s Green said. “It has to do with, when you do studies in more homogeneous settings or in smaller groups. There's similar questions to me about, how do things translate when you take it into a broader global study where you’ve got more heterogeneity of care?”Özlem Türeci, M.D., co-founder and chief medical officer of BioNTech, doesn’t think data reproducibility is a China question, either.“China's data is as good as data from any region. It’s also being adopted,” she said in an interview with Fierce. “The point is, if you want to have a global development program with global approvals and global launches, you have to conduct global studies. And that’s the reason why at some point regional studies or regional programs have to move into global and have to show that they can be globally confirmed.”BioNTech has its own rival to ivonescimab, the PD-L1xVEGF bispecific pumitamig, which it initially in-licensed, then fully acquired after buying out China’s Biotheus. BMS quickly signed on to the drug with a co-development and co-commercialization deal. At ASCO, the drug offered the first look at a global data set within the PD-(L)1xVEGF class in first-line NSCLC. Meanwhile, another Chinese asset could give BioNTech—which quickly ascended to global fame as a COVID vaccine maker—its first commercial oncology product. Licensed from China’s Duality Biologics, the HER2 ADC trastuzumab pamirtecan is moving toward an FDA filing after a positive readout in previously treated endometrial cancer. BioNTech got trastuzumab pamirtecan and another ADC from Duality for $170 million upfront in 2023, a time when Chinese biotechs were reeling from a pandemic crunch. Today, as asset quality rises, Chinese drug candidates may be harder to pocket for buyers despite their abundance. In the words of Evaluate analyst Mark Lansdell, China is “not a bargain basement anymore.” While the number of total cross-border licensing deals of Chinese biotech products increased by 120% from 2022 to 2025, the total upfront value jumped about 400%, from $1.1 billion in 2022 to $5.6 billion last year, according to Evaluate. The geopolitical shadowAbove the scientific discussions and deal talks, the dark cloud of geopolitics hovered over the Chicago convention center. Going forward, accessing China's biotech assets could become more difficult for U.S. companies as calls for restricting cross-border deals through the COINS Act grow louder. To some, the solution to maintaining the U.S.’ leadership in biotech is blocking China, along with any collaborations with the country. But others, like Pfizer’s Bourla, have pushed back on this mentality.“[The U.S.] should stop trying with all the heart and brains that they have to put 80% of their effort [on] how to slow down China,” Bourla said during the podcast. “Very big mistake. Because it’s a waste of resources and brain power because you will never slow them down. The genie is out of the bottle. We should put 80% of our focus and effort [on] how to become better than China.”From the U.S. biotech industry’s side, Bruce Booth, partner at Atlas Venture, echoed the sentiment in a June 2 blog post, framing China’s rise as “more opportunity than threat” and “a healthy forcing function to raise the game for everyone.” Still, beneath the big headlines, the friction was felt on the ground at ASCO.“China biotech presence in ASCO [this year] is not as many as the peak years in my memory,” observed Leon Tang, Ph.D., founder of the business development consultancy InScienceWeTrust BioAdvisory, pointing to rising travel costs and visa uncertainty as common concerns.Yet, the pioneers of the space remain undeterred. As more Chinese drugs vie to stage their own Carvykti moment, Frank Fan, M.D., Ph.D., the scientific mind behind the cell therapy’s breakthrough, returned to ASCO this year with a new proposal: an off-the-shelf CAR-T platform with potential for unprecedented production scalability without the need for gene editing. His new company, Wondercel Therapeutics, debuted early data from four patients with diffuse large B-cell lymphoma, showing early signs that its candidate can avoid premature clearance by the host immune system while achieving CAR-T expansion at levels similar to that of autologous CAR-T inside a patient’s body.For his new platform, Fan again hopes to deploy the same partnership model that built Legend—even if a COINS Act expansion would mean a deal with a U.S. company like Carvykti’s partner J&J would not be possible.“Even if obstacles do arise in the future, we still have Europe, Japan and other regions to partner with,” Fan said. “As long as we maintain innovation, and as long as international intellectual property laws remain intact, we remain confident.”Editor's note: Zoey Becker and Darren Incorvaia contributed reporting.

01 Jun 2026

·www.biospace.com

Ascentage Pharma Presents Data on Olverembatinib in CML-LBP and Ph+ BCP-ALL at ASCO 2026

ROCKVILLE, Md. and SUZHOU, China, May 31, 2026 (GLOBE NEWSWIRE) -- Ascentage Pharma Group International (NASDAQ: AAPG; HKEX: 6855), a global, commercial-stage, integrated biopharmaceutical company engaged in the discovery, development and commercialization of novel therapies to address unmet medical needs in cancer, today announced results from a Phase Ib study evaluating olverembatinib (HQP1351), the company’s core product, in combination with bispecific T-cell engager antibody (immunotherapy) blinatumomab in patients with lymphoid blast phase chronic myeloid leukemia (CML-LBP) or Philadelphia chromosome-positive B-cell precursor acute lymphoblastic leukemia (Ph+ BCP-ALL) were presented in a rapid oral presentation at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting. The ASCO Annual Meeting is the world’s most prominent scientific gathering in the clinical oncology community, showcasing cutting-edge research in clinical oncology and advanced cancer therapies. This year marks Ascentage Pharma’s ninth consecutive appearance at the ASCO Annual Meeting. A total of six studies involving three of the Company’s key assets were selected for presentation, including three rapid oral presentations. Data from this rapid oral presentation marks the first disclosure of olverembatinib combined with blinatumomab in international patients. The combination regimen demonstrated encouraging clinical activity in patients with relapsed/refractory Ph+ BCP-ALL or CML-LBP, with strong response rates and minimal residual disease (MRD) clearance. In terms of safety, the combination regimen was generally well tolerated, with a safety pro with individual agent toxicities. Olverembatinib is a novel drug developed by Ascentage Pharma and represents the first third-generation BCR-ABL inhibitor approved in China. Olverembatinib is currently being jointly commercialized in China by Ascentage Pharma and Innovent Biologics. The drug is currently approved in China for: adult patients with tyrosine kinase inhibitor (TKI)-resistant chronic-phase chronic myeloid leukemia (CML-CP) or accelerated-phase CML (CML-AP) harboring the T315I mutation; and adult patients with CML-CP resistant to and/or intolerant of first- and second-generation TKIs, with all approved indications now covered by the China National Reimbursement Drug List (NRDL). Ascentage Pharma is currently conducting three global registrational Phase III studies to evaluate olverembatinib in multiple indications, including CML-CP, newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL), and succinate dehydrogenase (SDH)-deficient gastrointestinal stromal tumors (GIST), with two of these studies having been cleared by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Ascentage Pharma has signed an exclusive option agreement to enter into an exclusive license agreement with Takeda for olverembatinib. In the event that Takeda exercises the option, Takeda would license the global rights to develop and commercialize olverembatinib in all territories outside of, among others, mainland China, Hong Kong, Macau, and Taiwan, China. Professor Elias Jabbour, MD, the principal investigator of the study from the Department of Leukemia at The University of Texas MD Anderson Cancer Center , stated: “Patients with relapsed or refractory Ph-positive ALL or CML in lymphoid blast phase have a significant unmet medical need. The promising activity and tolerability observed with the combination of olverembatinib and blinatumomab highlight its potential as a novel, chemotherapy-free strategy in this difficult-to-treat setting.” Yifan Zhai, MD, Chief Medical Officer of Ascentage Pharma, said: “This rapid oral presentation marks the first validation in international patients of the therapeutic potential of olverembatinib combined with blinatumomab in CML-LBP and relapsed/refractory Ph+ BCP-ALL. These two diseases have long been considered among the most difficult-to-treat BCR-ABL-driven hematologic malignancies, representing terminal-stage settings with the poorest prognoses and fewest treatment options. The data presented are highly encouraging and may help to address the longstanding unmet need in blast phase disease. We look forward to advancing this program through further clinical studies and translating these findings into sustained patient benefit. Moving forward, we remain committed to our mission of addressing unmet clinical needs for patients worldwide by accelerating clinical development and bringing safe and effective therapies to patients as soon as possible.” Key highlights from the study presented at the 2026 ASCO Annual Meeting are as follows: Olverembatinib (HQP1351) combined with blinatumomab in patients with lymphoid blast phase chronic myeloid leukemia (CML-LBP) or Philadelphia chromosome-positive B-cell precursor acute lymphoblastic leukemia (Ph+ BCP-ALL) Abstract #: 6513 Presentation Type: Rapid Oral Presentation Session Title: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant First Author: Elias Jabbour, MD, Department of Leukemia, The University of Texas MD Anderson Cancer Center Key Highlights: Background: Olverembatinib has previously demonstrated clinical activity in TKI-resistant Ph+ hematologic malignancies. This study evaluated olverembatinib combined with blinatumomab in patients with relapsed/refractory (R/R) Ph+ B-cell precursor acute lymphoblastic leukemia (Ph+ BCP-ALL) or CML-LBP across global sites. Efficacy Data: A total of 91% (10/11) of patients achieved complete response (CR) or complete response with incomplete hematologic recovery (CRi). In addition, 67% (8/12) of patients achieved BCR::ABL1 negativity by PCR (≤0.01%), and 80% (8/10) achieved minimal residual disease (MRD) negativity by flow cytometry (≤0.01%). Safety Data: The combination regimen demonstrated a manageable safety profile, with most adverse events (AEs) being grade 1-2, consistent with the known toxicities of each agent. Conclusion: This study is the first to demonstrate the feasibility of olverembatinib combined with immunotherapy in international patients with CML-LBP and R/R Ph+ BCP-ALL. * Olverembatinib is currently under investigation and has not yet been approved by the US FDA. About Ascentage Pharma Ascentage Pharma Group International (NASDAQ: AAPG; HKEX: 6855) (“Ascentage Pharma” or the “Company”) is a global, commercial stage, integrated biopharmaceutical company engaged in the discovery, development and commercialization of novel, differentiated therapies to address unmet medical needs in cancer. The Company has built a rich pipeline of innovative drug products and candidates that include inhibitors targeting key proteins in the apoptotic pathway, such as Bcl-2 and MDM2-p53, next-generation kinase inhibitors, and protein degraders. The Company’s first approved product, olverembatinib, is the first novel third-generation BCR-ABL1 inhibitor approved in China for the treatment of patients with CML in chronic phase (CML-CP) with T315I mutations, CML in accelerated phase (CML-AP) with T315I mutations, and CML-CP that is resistant or intolerant to first and second-generation TKIs. It is covered by the China National Reimbursement Drug List (NRDL). Ascentage Pharma is currently conducting an FDA- and EMA-cleared registrational Phase III trial, called POLARIS-2, of olverembatinib for CML, as well as an FDA- and EMA-cleared registrational Phase III trials for patients with newly diagnosed Ph+ ALL, called POLARIS-1, and SDH-deficient GIST patients, called POLARIS-3. The Company’s second approved product, lisaftoclax, is a novel Bcl-2 inhibitor for the treatment of various hematologic malignancies. Lisaftoclax has been approved by China’s National Medical Products Administration (NMPA) for the treatment of adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have previously received at least one systemic therapy including Bruton’s tyrosine kinase (BTK) inhibitors. The Company is currently conducting four global registrational Phase III trials: the FDA- and EMA- cleared GLORA study of lisaftoclax in combination with BTK inhibitors in patients with CLL/SLL previously treated with BTK inhibitors for more than 12 months with suboptimal response; the GLORA-2 study in patients with newly diagnosed CLL/SLL; the GLORA-3 study in newly diagnosed, elderly and unfit patients with AML; and the FDA- and EMA-cleared GLORA-4 study in patients with newly diagnosed higher risk MDS. Leveraging its robust R&D capabilities, Ascentage Pharma has built a portfolio of global intellectual property rights and entered into global partnerships and other relationships with numerous leading biotechnology and pharmaceutical companies, such as Takeda, AstraZeneca, Merck, Pfizer, and Innovent, in addition to research and development relationships with leading research institutions, such as Dana-Farber Cancer Institute, Mayo Clinic, National Cancer Institute and the University of Michigan. For more information, visit Cautionary Note Regarding Forward-Looking Statements This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements, other than statements of historical facts, contained in this press release may be forward-looking statements, including statements that express Ascentage Pharma’s opinions, expectations, beliefs, plans, objectives, assumptions or projections regarding future events or future results of operations or financial condition. These forward-looking statements are subject to a number of risks and uncertainties as discussed in Ascentage Pharma’s filings with the SEC, including those set forth in the sections titled “Risk factors” and “Cautionary note regarding forward-looking statements” in its Annual Report on Form 20-F for the year ended December 31, 2025, filed with the SEC on April 29, 2026, the sections headed “Forward-looking Statements” and “Risks Factors” in the prospectus of the Company for its Hong Kong initial public offering dated October 16, 2019, and other filings with the SEC and/or The Stock Exchange of Hong Kong Limited where the Company’s ordinary shares are listed it has made or it makes from time to time that may cause actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. The forward-looking statements contained in this presentation do not constitute profit forecast by the Company’s management. As a result of these factors, you should not rely on these forward-looking statements as predictions of future events. The forward-looking statements contained in this press release are based on Ascentage Pharma’s current expectations and beliefs concerning future developments and their potential effects and speak only as of the date of such statements. Ascentage Pharma does not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Contact Information Investor Relations: Stella Yang Ascentage Pharma IR@ascentage.com +1 (301) 792-6286 Stephanie Carrington ICR Healthcare AscentageIR@icrhealthcare.com +1 (646) 277-1282 Media Relations: Sean Leous ICR Healthcare AscentagePR@icrhealthcare.com +1 (646) 866-4012

Phase 3Phase 1ASCOClinical ResultLicense out/in

100 Deals associated with Olverembatinib

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R&D Status

Approved

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Indication	Country/Location	Organization	Date
Aggressive-Phase Chronic Myelocytic Leukemia	China	Guangzhou Shunjian Biomedical Technology Co. Ltd.	24 Nov 2021
Chronic phase chronic myeloid leukemia	China	Guangzhou Shunjian Biomedical Technology Co. Ltd.	24 Nov 2021

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
SDH-deficient Gastrointestinal Stromal Tumors	Phase 3	China	Ascentage Pharma Group, Inc.	11 Nov 2024
SDH-deficient Gastrointestinal Stromal Tumors	Phase 3	China	Guangzhou Shunjian Biomedical Technology Co. Ltd.	11 Nov 2024
Philadelphia chromosome positive chronic myelogenous leukemia	Phase 3	United States	Ascentage Pharma Group, Inc.	05 Feb 2024
Philadelphia chromosome positive adult precursor acute lymphoblastic leukemia	Phase 3	United States	Ascentage Pharma Group, Inc.	31 Aug 2023
Philadelphia chromosome positive adult precursor acute lymphoblastic leukemia	Phase 3	China	Ascentage Pharma Group, Inc.	31 Aug 2023
Philadelphia chromosome positive adult precursor acute lymphoblastic leukemia	Phase 3	Australia	Ascentage Pharma Group, Inc.	31 Aug 2023
Philadelphia chromosome positive adult precursor acute lymphoblastic leukemia	Phase 3	Czechia	Ascentage Pharma Group, Inc.	31 Aug 2023
Philadelphia chromosome positive adult precursor acute lymphoblastic leukemia	Phase 3	France	Ascentage Pharma Group, Inc.	31 Aug 2023
Philadelphia chromosome positive adult precursor acute lymphoblastic leukemia	Phase 3	Italy	Ascentage Pharma Group, Inc.	31 Aug 2023
Philadelphia chromosome positive adult precursor acute lymphoblastic leukemia	Phase 3	Romania	Ascentage Pharma Group, Inc.	31 Aug 2023

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASCO2026	Not Applicable	Philadelphia positive acute lymphocytic leukaemia	253	Olverembatinib (Philadelphia chromosome-positive acute lymphoblastic leukemia)	moqbigodlf(fxlojsgyda) = dfhirtquwr sqgebooyfb (gpujylnhbq, 67.0 - 96.0) View more	Positive	29 May 2026
NCT04260022 (HQP1351CU101, ASCO2026)	Phase 1	Philadelphia positive acute lymphocytic leukaemia \| Blast Phase Chronic Granulocytic Leukemia	9	Olverembatinib + blinatumomab (R/R Ph+ BCP-ALL or CML-LBP)	zysaifsbkj(cgzwsuftcu) = Four patients experienced grade 3 AEs related to olverembatinib, including increased lipase, neutropenia, thrombocytopenia, and pancreatitis. hdsmirupis (jyugkqtaog ) View more	Positive	29 May 2026
NCT06423911 (POLARIS-2, ASCO2026)	Phase 3	Chronic phase chronic myeloid leukemia T315I mutation	270	Bosutinib	nmixngmvyd(bmbdovluzo) = gaslfuiacf iecixjthum (zzsrebsqiu )	Positive	29 May 2026
NCT06423911 (POLARIS-2, ASCO2026)	Phase 3	Chronic phase chronic myeloid leukemia T315I mutation	270	Olverembatinib (T315I mutation)	ndybpamxcn(coinvviswh) = zmizufeuzn knmcmcuigf (fbeynosgsh )	Positive	29 May 2026
ASH2025	Not Applicable	Chronic phase chronic myeloid leukemia	63	Olverembatinib	eurrdqgvin(hrjicrcydb) = lcgggsytlp thtxdggygp (lsftbecmzs ) View more	Positive	06 Dec 2025
ASH2025	Not Applicable	Chronic phase chronic myeloid leukemia	63	original TKI therapy	eurrdqgvin(hrjicrcydb) = lkjoifumkh thtxdggygp (lsftbecmzs ) View more	Positive	06 Dec 2025
ASH2025	Not Applicable	Blast Phase Chronic Granulocytic Leukemia	64	Olverembatinib	udomywoaqj(lstssrdyul) = Treatment-related adverse events in olverembatinib cohort 52.4% (11/21) of patients. Six (28.6%) developed grade 3/4 neutropenia. Cardiovascular Events were observed in two patients, including deep vein thrombosis (n=1) and pericardial effusion (n=1). uzjxywyrya (xbqgexzgwt ) View more	Positive	06 Dec 2025
ASH2025	Not Applicable	Blast Phase Chronic Granulocytic Leukemia	64	1/2G-TKI		Positive	06 Dec 2025
ASH2025	Not Applicable	Chronic Myelogenous Leukemia	167	Olverembatinib therapy	ozhalbvyvb(fpczvnxlfc) = wgkvthqatb gpdcweosss (sqemdmfwyp ) View more	Positive	06 Dec 2025
NCT03594422 (Signal Transduct Target Ther) Manual	Phase 1	SDH-deficient Gastrointestinal Stromal Tumors SDH deficient	66	Olverembatinib (TKI-failed, evaluable)	dkgzufiywb(ghsddtprlz) = troeceacjr wdhrwhmqso (nuadfhlkwr, 9 - 43.7) View more	Positive	04 Nov 2025
NCT05594784 (Pubmed \| Leukemia)	Phase 2	Philadelphia positive acute lymphocytic leukaemia	79	Olverembatinib + Venetoclax + Reduced-intensity chemotherapy	ievftvpllh(hnwfqzenei) = ssezuwmcnp vpgwosukjc (zjjtuyeprd ) View more	Positive	01 Aug 2025
PS1367 (EHA2025) Manual	Not Applicable	Ph-Like Acute Lymphoblastic Leukemia \| Philadelphia chromosome positive chronic myelogenous leukemia First line	24	olverembatinib(40mg once every other day) in combination with blinatumomabolverembatinib(40mg once every other day) in combination with blinatumomab	nbtxpijtti(scxhjpennp) = achieved in 17 patients who adhered to the treatment within the first 3 months of the treatment course vgxhgkyscr (ojagtblsww )	Positive	14 Jun 2025
EHA 12025 \| EHA 22025 Manual	Phase 2	Hematologic Neoplasms \| Chromosome 8p11 myeloproliferative syndrome FGFR1 Rearrangement	13	olverembatinib 40mgolverembatinib 40mg (chronic-phase)	yewezvprbm(nuqpaobwri) = rnrhhmjkvt tpqzrzjlzb (xujpwhnarf )	Positive	13 Jun 2025
EHA 12025 \| EHA 22025 Manual	Phase 2		13	olverembatinib 40mg QOD +inotuzumab ozogamicin (blast-phase)	ojtirntlhu(plzrguognh) = bwqzjfygfy gosyuzqtis (qtmjhwfbzu )	Positive	13 Jun 2025

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